FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
61919-589
11-digit product format
619190589
Labeler code
61919
Product ID
61919-589_f214c7ce-fa19-b6e1-e053-2a95a90a24a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077284
Marketing category
ANDA
Marketing start
2019-10-01
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-589-602025-01-30C16284748780-12cef2736-66f9-d83d-e063-dadaa90ab31fBUPROPION HYDROCHLORIDE
61919-589-302020-01-31C16284748780-19d75b9d0-218b-f424-e053-dadaa90a57ceBUPROPION HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-589-60BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE604
61919-589-30BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-589-30EA - Each61919-589dd65769e-8ce4-4bd1-9879-b0342b0278f912019-08-06
61919-589-60EA - Each61919-5896ca4ccc2-e51e-461a-8892-0cf3b7fde3ad12019-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-589BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT_RX]4Legacy NDC, 1 package rows20230113_93df2f0a-a343-95cf-e053-2a95a90aaeb3.zip
61919-589BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2Legacy NDC, 1 package rows20150807_83fa3e3f-29b9-4aae-9e7b-9175386df144.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN93df2f0a-a343-95cf-e053-2a95a90aaeb34
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD93df2f0a-a343-95cf-e053-2a95a90aaeb34
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY93df2f0a-a343-95cf-e053-2a95a90aaeb34
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN83fa3e3f-29b9-4aae-9e7b-9175386df1442
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD83fa3e3f-29b9-4aae-9e7b-9175386df1442
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY83fa3e3f-29b9-4aae-9e7b-9175386df1442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-589-306191905893030 in 1 BOTTLEHistorical
61919-589-606191905896060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-589-60) 2019-10-010000-00-00NoNoCurrent